Social Aspects of Drug Discovery, Development and Commercialization

1st Edition - February 11, 2016
Authors: Odilia Osakwe, Syed A.A. Rizvi
Language: English
Paperback ISBN:
9 7 8 - 0 - 1 2 - 8 0 2 2 2 0 - 7
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 0 2 4 9 7 - 3

Social Aspects of Drug Discovery, Development and Commercialization provides an insightful analysis of the drug discovery and development landscape as it relates to society.… Read more

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Social Aspects of Drug Discovery, Development and Commercialization provides an insightful analysis of the drug discovery and development landscape as it relates to society. This book examines the scientific, legal, philosophical, economic, political, ethical and cultural factors that contribute to drug development. The pharmaceutical industry is under scrutiny to develop safer and more effective drugs in a quicker and more affordable manner. Recent criticism and debates have emphasized varying opinions on the issues concerning the drug discovery and development process.

This book provides thoughtful and valuable discussions and analysis of the social challenges and potential opportunities through all stages of the pharmaceutical process, from inception through marketing. With a unique focus on the social factors that increasingly play a role in how drug development is planned, structured, and executed throughout the drug product lifecycle, this is an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society.

Dedication
Preface
Introduction
Section I: Pharmaceutical Industry, Society, and Governance
- Chapter 1: Pharmaceutical Regulation: The Role of Government in the Business of Drug Discovery
  - Abstract
  - 1.1. Introduction
  - 1.2. The legal instruments
  - 1.3. The National Regulatory Authorities and Administration
  - 1.4. Analytical framework for regulatory approval: benefit–risk assessment
  - 1.5. The pharmaceutical product life cycle
  - 1.6. The global pharmaceutical industry: harmonization and partnerships
  - 1.7. Modernization of the global pharmaceutical systems: regulatory strategies, roadmap initiatives, and partnerships
- Chapter 2: Trends in Innovation and the Business of Drug Discovery
  - Abstract
  - 2.1. Introduction
  - 2.2. Evolutionary trends in pharmaceutical innovation
  - 2.3. Advances in pharmaceutical innovation technology
  - 2.4. Select medical milestones of 2014
  - 2.5. Factors contributing to pharmaceutical innovation setback
  - 2.6. Case: challenges in antimicrobial drug discovery
  - 2.7. Consequence of innovation setback
  - 2.8. Strategies and approaches to addressing innovation failure
  - 2.9. Concluding remarks
- Chapter 3: Cash Flow Valley of Death: A Pitfall in Drug Discovery
  - Abstract
  - 3.1. Introduction
  - 3.2. Product valuation as an investment decision-making tool
  - 3.3. Challenges associated with the valley of death
  - 3.4. Firms involved in the pharmaceutical value chain
  - 3.5. Strategies for bridging the Valley of Death and innovation failure
  - 3.6. Funding models
  - 3.7. Nongovernmental funding models
  - 3.8. Other financial concepts
  - 3.9. Private–public sector groups
Section II: Drug Discovery Cycle I: Discovery and Preclinical Drug Development
- Chapter 4: Prediscovery Research: Challenges and Opportunities
  - Abstract
  - 4.1. Introduction
  - 4.2. Models of human disease biology
  - 4.3. Diseases considered in biopharmaceutical research and development
  - 4.4. Modern trends in drug discovery
  - 4.5. Current challenges in early drug discovery
- Chapter 5: The Significance of Discovery Screening and Structure Optimization Studies
  - Abstract
  - 5.1. Introduction
  - 5.2. Screening tools in drug discovery
  - 5.3. In silico models in drug discovery and design
  - 5.4. From hit to lead: summary of compound optimization in drug discovery
- Chapter 6: Preclinical In Vitro Studies: Development and Applicability
  - Abstract
  - 6.1. Introduction
  - 6.2. Predictability of preclinical disease models
  - 6.3. Trends in preclinical drug development
  - 6.4. Relevance of ADME/PK studies
  - 6.5. Experimental tools used in preclinical development
  - 6.6. Drug eliminating agents and mechanisms
  - 6.7. Application of zebrafish as a model whole organism: a landmark in preclinical development
- Chapter 7: Animal Utilization in Drug Development: Clinical, Legal, and Ethical Dimensions
  - Abstract
  - 7.1. Introduction
  - 7.2. The scientific value of animal studies: pharmacology objectives
  - 7.3. Laboratory animals model in the frontiers of drug discovery
  - 7.4. Relationships in animal taxonomy and implications in pharmaceutical research and development
  - 7.5. The effect of species differences on study results
  - 7.6. How reliable is the animal toxicity information generated across the animal species?
  - 7.7. Landmarks in preclinical development: species selection and rationale
  - 7.8. Animal models in the development of biopharmaceuticals: the exceptional use of nonhuman primates
  - 7.9. Legal accommodations on the use of animals in pharmaceutical research and development
  - 7.10. Animal alternatives in drug development: replacing, reducing, and refinement of animals
- Chapter 8: Pharmaceutical Formulation and Manufacturing Development: Strategies and Issues
  - Abstract
  - 8.1. Introduction
  - 8.2. Regulatory aspects of pharmaceutical development
  - 8.3. Formulation and manufacturing in pharmaceutical development
  - 8.4. Clinical trials materials
  - 8.5. Concepts used in pharmaceutical development
  - 8.6. Drug shortages
  - 8.7. Manufacturing problems leading to drug shortages
  - 8.8. Addressing drug shortages: strategies
Section III: The Drug Discovery Cycle II: Clinical Development
- Chapter 9: Clinical Development: Ethics and Realities
  - Abstract
  - Part I.
  - Part II. Clinical development of candidate drugs
  - Part III. Clinical trial ethics
- Chapter 10: Pharmacogenomics in Drug Discovery, Prospects and Clinical Applicability
  - Abstract
  - 10.1. Introduction
  - 10.2. Genetic variations and implications in drug development
  - 10.3. The effectiveness of clinical implementation of pharmacogenomics
  - 10.4. Promising outcomes associated with clinical application pharmacogenomics: cases
  - 10.5. Economic and social implications of pharmacogenomics application
  - 10.6. National regulatory agencies on pharmacogenomics implementation
Section IV: The Drug Discovery Cycle III: Authorization and Marketing
- Chapter 11: Patents, Exclusivities, and Evergreening Strategies
  - Abstract
  - 11.1. Introduction: patents and exclusive marketing rights
  - 11.2. US Patent Law Amendments Act of 1984
  - 11.3. The interplay of patents and exclusivities during the product lifecycle
  - 11.4. Patents in the global pharmaceutical market place
  - 11.5. Evergreening
  - 11.6. Conclusions
- Chapter 12: Drug Pricing and Control for Pharmaceutical Drugs
  - Abstract
  - 12.1. Introduction
  - 12.2. Drug assessment and pricing in various geographical locations
  - 12.3. Pharmaceutical drug pricing and ethics
- Chapter 13: Direct-to-Consumer Advertising
  - Abstract
  - 13.1. Introduction
  - 13.2. Ethics and relevance of pharmaceutical advertising
  - 13.3. Pharmaceutical advertising and government control
  - 13.4. Prescription medicine advertising codes
  - 13.5. Conclusions
Index

Odilia Osakwe

Dr. Odilia Osakwe has published 25 titles, including 1 book (edited), 24 articles in peer reviewed platform including journal articles, scholarly magazines, newsletters and technical notes. And has authored 10 papers/posters and oral presentations in major international professional meetings. Odilia has reviewed numerous manuscripts for different academic journals. Aside from those activities, she served as an editorial board member with Pharmaceutical Science Group of Canada for 3 years reviewing and editing articles with active contribution towards several of the published front cover topics. Odilia received her undergraduate degree from Abia state University and her Masters in Chemistry from Tennessee State University. Within this period, she worked with the Tennessee State Department of Laboratory Services. Following completion of a Master Degree in Chemistry, she took on a two-year post graduate fellowship, which was granted by Vanderbilt University, Nashville, Tennessee; completed in the department of pharmacology of Vanderbilt University Medical Centre. She joined a doctoral program with the department of pharmaceutical Sciences of Mercer University, Atlanta, Georgia and earned a PhD degree. During much of this period, starting from the second year into the doctoral program, she joined the Georgia Perimeter College, Atlanta, Georgia, teaching Chemistry courses for two years till the end of the program. During the all-but-dissertation stage, (ABD), Odilia received a Student Research Fellowship with the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia where she worked as a researcher with the immunology laboratories of National Center for Immunization and Respiratory Diseases (NCIRD) in the Division of Bacterial Diseases (DBD), using the state-of-the-art instrumentation for validation of immunological assays. Further on, Odilia received a competitive National Science and Engineering Research Council of Canada (NSERC) award for Industrial Research and Development Postdoctoral Fellowship (IRDF-NSERC). The two-year training was accomplished at the University of Toronto Hospital Network, Industrial BioDevelopment Laboratory (IBDL) department where she took the lead of the Research and Development activities which include technical oversight and training of the University of Toronto undergraduates on various projects, with published results. Odilia works with Devik Pharma Inc., also a board member of the North American Institute of Pharmaceutical Technology, Scarborough, Ontario, Canada where she undertakes administrative and scholarly duties in the industrial pharmaceutical sector. She is an Adjunct Faculty with Ryerson University, Toronto, Ontario, Canada and Seneca College of Arts and Technology, Toronto, Ontario, Canada, teaching several courses in the Industrial Pharmaceutical Technology program.

Affiliations and expertise

Industrial BioDevelopment Laboratory, UHN-MaRS Centre, Toronto Medical Discovery Tower and Ryerson University, Toronto, Canada

Syed A.A. Rizvi

Dr. Rizvi is currently an Associate Professor of Pharmaceutical Sciences at the College of Pharmacy, Nova Southeastern University in Fort Lauderdale, Florida. Dr. Rizvi earned his Bachelor of Science (B.Sc) and Master of Science (M.Sc) degrees from the University of Karachi, Pakistan, with expertise in Organic and Natural Product Chemistry. Dr. Rizvi then came to the United States and pursued an M.S and Ph.D combined degree program at the Center for Biotechnology and Drug Design, Department of Chemistry, Georgia State University, Atlanta, Georgia, followed by another Ph.D., at the College of Pharmacy and Health Sciences, Department of the Pharmaceutical Sciences, Mercer University, Atlanta, Georgia, in collaboration with Renovo Research, LLC. Furthermore, Dr. Rizvi pursued postdoctoral research in the laboratory of Dr. Fredric M. Menger (Charles Howard Candler Professor) at the Sanford S. Atwood Chemistry Center, Emory University. Dr. Rizvi also conducted research as a visiting scientist in the area of pharmaceutical ionic liquids, in the laboratory of Dr. Robin D. Rogers (Robert Ramsay Chair of Chemistry, Distinguished Research Professor and Director, Center for Green Manufacturing) at the Department of Chemistry, The University of Alabama. Recently, Dr. Rizvi finished course of studies leading to Master of Business Administration (MBA) degree with specialization in Pharmaceutical Marketing and Management from Aspen University and a certificate in Executive Leadership from Johnson Graduate School of Management, eCornell Professional Development Programs, Cornell University.

Dr. Rizvi has published over 100 peer-reviewed articles, including two most highly rated articles, two cover articles and citations in respected textbooks. Dr. Rizvi serves as editor-in-chief, associate editor, executive editor, editorial board member and review manuscripts and books for many well known scientific publishers. Dr. Rizvi’s research interests include micro and nanotechnology for drug delivery, controlled release formulations, solid state chemistry of drugs, surface chemistry and analytical chemistry, material and organic chemistry, natural product chemistry, and immunology. In his free time, Dr. Rizvi enjoys cooking and practicing martial arts.

Affiliations and expertise

Associate Professor of Pharmaceutical Sciences at the College of Pharmacy, Nova Southeastern University, Fort Lauderdale, FL, USA

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health